The top antitrust enforcers in the U.S. — the Department of Justice Antitrust Division (“DOJ”) and the Federal Trade Commission (“FTC”) — are tasked with preserving competition in the marketplace, including the market for health care products and services.  Competition benefits consumers through lower prices, increased availability of products and services, higher quality, and greater

The Food and Drug Administration (FDA) recently introduced a new webpage for reporting allegations of regulatory violations by medical device manufacturers or marketers. The new webpage, launched on October 21, 2016, enables any person—including current or former employees, competitors, or even plaintiffs’ attorneys—to submit a report to FDA regarding a broad variety of potential violations. 

The newly formed mHealth working group is tasked with developing guidelines for use in assessing the validity and reliability of data that is collected and processed by health and wellbeing apps. Ultimately, the guidelines will inform European Commission policy with respect to improving the safety and transparency of health information collected by mobile apps.

In April 2014, the European Commission published a Green Paper, which launched a public consultation on the challenges faced by the European mHealth market. The results of the public consultation were published in January 2015. Two open stakeholder meetings (held on 12 May 2015 and 6 July 2015) further emphasized the usefulness of a common mHealth methodological framework.


Continue Reading

Welcome to your first edition of the Digital Health Download Blog. Our mission is to provide substantive cross-functional analysis of noteworthy digital health industry developments. For decades, Arnold & Porter LLP’s FDA and Healthcare practice has been a leader in helping pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, respond